Special Warning : אזהרת שימוש

4.4   Special warnings and precautions for use

Suspicion of allergic or anaphylactic type reactions requires immediate discontinuation of the injection. In case of shock, standard medical treatment for shock should be implemented.

Albumin should be used with caution in conditions where hypervolaemia and its consequences or haemodilution could represent a special risk for the patient. Examples of such conditions are:

-   Decompensated cardiac insufficiency
-   Hypertension
-   Oesophageal varices
-   Pulmonary oedema
-   Haemorrhagic diathesis
-   Severe anaemia
-   Renal and post-renal anuria

The colloid-osmotic effect of human albumin 200 mg/ml is approximately four times that of blood plasma. Therefore, when concentrated albumin is administered, care must be taken to assure adequate hydration of the patient. Patients should be monitored carefully to guard against circulatory overload and hyperhydration.

200-250 mg/ml human albumin solutions are relatively low in electrolytes compared to the
40-50 mg/ml human albumin solutions. When albumin is given, the electrolyte status of the patient should be monitored (see section 4.2) and appropriate steps taken to restore or maintain the electrolyte balance.

50 mL vial:
This medicinal product contains 115 – 149.5 mg sodium per vial, equivalent to 5.8 – 7.5 % of the WHO recommended maximum daily intake of 2 g sodium for an adult.

100 mL vial:
This medicinal product contains 230 - 299 mg sodium per vial, equivalent to 11.5 - 15 % of the WHO recommended maximum daily intake of 2 g sodium for an adult.

Albumin solutions must not be diluted with water for injections as this may cause haemolysis in recipients.

If comparatively large volumes are to be replaced, controls of coagulation and haematocrit are necessary. Care must be taken to ensure adequate substitution of other blood constituents (coagulation factors, electrolytes, platelets, and erythrocytes).

Hypervolaemia may occur if the dosage and rate of infusion are not adjusted to the patient´s circulatory situation. At the first clinical signs of cardiovascular overload (headache, dyspnoea, jugular vein congestion), or increased blood pressure, raised central venous pressure and pulmonary oedema, the infusion is to be stopped immediately.

Standard measures to prevent infections resulting from the use of medicinal products prepared from human blood or plasma include selection of donors, screening of individual donations and plasma pools for specific markers of infection and the inclusion of effective manufacturing steps for the inactivation/removal of viruses. Despite this, when medicinal products prepared from human blood or plasma are administered, the possibility of transmitting infective agents cannot be totally excluded. This also applies to unknown or emerging viruses and other pathogens.

There are no reports of virus transmissions with albumin manufactured to European Pharmacopoeia specifications by established processes.

It is strongly recommended that every time that Human Albumin Takeda 200 mg/ml is administered to a patient, the name and batch number of the product are recorded in order to improve the traceability of biological medicinal products and maintain a link between the patient and the batch of the product.

Effects on Driving

4.7   Effects on ability to drive and use machines
Human Albumin Takeda 200 mg/ml has no influence on the ability to drive and use machines.